Recalls / Class II
Class IID-0312-2020
Product
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10
- Affected lot / code info
- all lots within expiry.
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm
- Firm
- Novitium Pharma LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 70 Lake Dr, N/A, East Windsor, New Jersey 08520-5321
Distribution
- Quantity
- 12312 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-10-25
- FDA classified
- 2019-11-10
- Posted by FDA
- 2019-11-20
- Terminated
- 2021-03-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0312-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.